ID

41409

Beschreibung

Combination Therapy With NC-6004 and Gemcitabine in Advanced Solid Tumors or Non-Small Cell Lung, Biliary and Bladder Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02240238

Link

https://clinicaltrials.gov/show/NCT02240238

Stichworte

Versionen (3)
  1. 19.01.19 19.01.19 -
  2. 28.09.20 28.09.20 -
  3. 01.10.20 01.10.20 -
Rechteinhaber

see on clinicaltrials.gov

Hochgeladen am

1. Oktober 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

Englisch

Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
(part 1 only) have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
Beschreibung

Histologically or cytologically confirmed advanced solid neoplasms, recurrent, unresponsive to treatment or with contraindication to standard therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0280100
UMLS CUI [1,2]
C0277556
UMLS CUI [2,1]
C0280100
UMLS CUI [2,2]
C0205269
UMLS CUI [3,1]
C0280100
UMLS CUI [3,2]
C1301624
UMLS CUI [3,3]
C1442989
UMLS CUI [3,4]
C0087111
UMLS CUI [4,1]
C0280100
UMLS CUI [4,2]
C1300072
UMLS CUI [5,1]
C0280100
UMLS CUI [5,2]
C0449575
UMLS CUI [6,1]
C0280100
UMLS CUI [6,2]
C1265900
(part 2 only) have histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc and have received 1 or 2 lines of prior chemotherapy or targeted therapy for stage iiib or iv nsclc (second- or third-line).
Beschreibung

Histologically or cytologically confirmed NSCLC stage iiiv or iv after prior chemotherapy or targeted therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0007131
UMLS CUI [1,2]
C0449575
UMLS CUI [2,1]
C0007131
UMLS CUI [2,2]
C1265900
UMLS CUI [3,1]
C0007131
UMLS CUI [3,2]
C1300072
UMLS CUI [4,1]
C0007131
UMLS CUI [4,2]
C1514457
UMLS CUI [5,1]
C0007131
UMLS CUI [5,2]
C1514463
UMLS CUI [5,3]
C2985566
have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1.
Beschreibung

Measurable Disease (recist)

Datentyp

boolean

Alias
UMLS CUI [1]
C1709926
UMLS CUI [2]
C1513041
eastern cooperative oncology group (ecog) performance status of 0 to 1
Beschreibung

Ecog performance

Datentyp

boolean

Alias
UMLS CUI [1]
C1520224
have adequate bone marrow reserve, liver function, and renal function
Beschreibung

Adequate bone marrow reserve, liver and renal function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0232741
UMLS CUI [3]
C0232804
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
have received prior platinum therapy in the past 3 months
Beschreibung

Recent platinum therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3536920
UMLS CUI [1,2]
C0332185
have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
Beschreibung

Recent therapy with or refractory to cisplatin and gemcitabine

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0338265
UMLS CUI [1,2]
C0332185
UMLS CUI [2,1]
C0338265
UMLS CUI [2,2]
C0205269
unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
Beschreibung

Unresolved toxicity from radio-, chemo- or other targeted therapy like investigational therapy

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0600688
UMLS CUI [1,2]
C0443342
UMLS CUI [1,3]
C0279134
UMLS CUI [2,1]
C0600688
UMLS CUI [2,2]
C0443342
UMLS CUI [2,3]
C1514457
UMLS CUI [3,1]
C0600688
UMLS CUI [3,2]
C0443342
UMLS CUI [3,3]
C1514463
UMLS CUI [3,4]
C2985566
UMLS CUI [4,1]
C0600688
UMLS CUI [4,2]
C0443342
UMLS CUI [4,3]
C1514463
UMLS CUI [4,4]
C0949266
pregnant or breast feeding
Beschreibung

Pregnant, breast feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Solid Tumors, NSCLC, Biliary and Bladder Cancer NCT02240238

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Histologically or cytologically confirmed advanced solid neoplasms, recurrent, unresponsive to treatment or with contraindication to standard therapy
Item
(part 1 only) have a histologically or cytologically confirmed diagnosis of advanced solid tumor that has relapsed or is refractory to standard curative or palliative therapy or has a contraindication to standard therapy.
boolean
C0280100 (UMLS CUI [1,1])
C0277556 (UMLS CUI [1,2])
C0280100 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
C0280100 (UMLS CUI [3,1])
C1301624 (UMLS CUI [3,2])
C1442989 (UMLS CUI [3,3])
C0087111 (UMLS CUI [3,4])
C0280100 (UMLS CUI [4,1])
C1300072 (UMLS CUI [4,2])
C0280100 (UMLS CUI [5,1])
C0449575 (UMLS CUI [5,2])
C0280100 (UMLS CUI [6,1])
C1265900 (UMLS CUI [6,2])
Histologically or cytologically confirmed NSCLC stage iiiv or iv after prior chemotherapy or targeted therapy
Item
(part 2 only) have histologically or cytologically confirmed diagnosis of stage iiib or iv nsclc and have received 1 or 2 lines of prior chemotherapy or targeted therapy for stage iiib or iv nsclc (second- or third-line).
boolean
C0007131 (UMLS CUI [1,1])
C0449575 (UMLS CUI [1,2])
C0007131 (UMLS CUI [2,1])
C1265900 (UMLS CUI [2,2])
C0007131 (UMLS CUI [3,1])
C1300072 (UMLS CUI [3,2])
C0007131 (UMLS CUI [4,1])
C1514457 (UMLS CUI [4,2])
C0007131 (UMLS CUI [5,1])
C1514463 (UMLS CUI [5,2])
C2985566 (UMLS CUI [5,3])
Measurable Disease (recist)
Item
have measurable disease per response evaluation criteria in solid tumors (recist) version 1.1.
boolean
C1709926 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Ecog performance
Item
eastern cooperative oncology group (ecog) performance status of 0 to 1
boolean
C1520224 (UMLS CUI [1])
Adequate bone marrow reserve, liver and renal function
Item
have adequate bone marrow reserve, liver function, and renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0232741 (UMLS CUI [2])
C0232804 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Recent platinum therapy
Item
have received prior platinum therapy in the past 3 months
boolean
C3536920 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Recent therapy with or refractory to cisplatin and gemcitabine
Item
have received prior cisplatin and gemcitabine concomitantly within the last 6 months or are refractory to cisplatin and gemcitabine.
boolean
C0338265 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0338265 (UMLS CUI [2,1])
C0205269 (UMLS CUI [2,2])
Unresolved toxicity from radio-, chemo- or other targeted therapy like investigational therapy
Item
unresolved toxicity from prior radiation, chemotherapy, or other targeted treatment, including investigational treatment
boolean
C0600688 (UMLS CUI [1,1])
C0443342 (UMLS CUI [1,2])
C0279134 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0443342 (UMLS CUI [2,2])
C1514457 (UMLS CUI [2,3])
C0600688 (UMLS CUI [3,1])
C0443342 (UMLS CUI [3,2])
C1514463 (UMLS CUI [3,3])
C2985566 (UMLS CUI [3,4])
C0600688 (UMLS CUI [4,1])
C0443342 (UMLS CUI [4,2])
C1514463 (UMLS CUI [4,3])
C0949266 (UMLS CUI [4,4])
Pregnant, breast feeding
Item
pregnant or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
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